Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Prostatic Neoplasms

Hemorrhage

Pelvic Neoplasms

Proctitis

Gastroenteritis

Gastrointestinal Diseases

Rectal Diseases

Intestinal Diseases

Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.

FDA approved endoscopic device for use in coagulation of tissue in the digestive tract using radiofrequency energy.

HALO90 Ablation catheter

Jeffrey M. Marks, MD

This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by the side effects of radiation treatments that can lead to bleeding).

In medical procedures, the RF energy used with this device, has been historically used in shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device has been used in areas outside the esophagus (inner lining of the throat), including the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using the HALO device, may be one method to control the bleeding.

The purpose of this study is to evaluate the effectiveness and record the results of treatment of radiation proctitis using the HALO device.

This study is intended to prospectively gather information regarding the performance of an endoscope-mounted radiofrequency (RF) energy device, which utilizes RF energy for the coagulation of gastrointestinal tissue in the setting of bleeding of radiation proctitis. The study device, the HALO90 Ablation catheter, has an FDA 510(k) clearance for human use.

The study design is a single-site, prospective clinical trial to gather performance data regarding a 510(k)-cleared, endoscopically-guided radiofrequency energy ablation device for the coagulation of hemorrhagic radiation proctitis.

Study subjects will have experienced bloody stools due to proctitis following pelvic radiation for cancers of the prostate or uterine endometrium. The study will include female and male adult patients who have received pelvic radiotherapy for such indications as cancer of the prostate or endometrium and have subsequently experienced recurrent hemorrhagic radiation proctitis.

As part of this protocol, focal areas of the epithelial lining of the diseased colon, rectum, and/or anus will be treated with the study device. The aim is to obtain information about the hemostatic effect of this device. The treatment settings evaluated in this study have been previously established with this device in the esophagus in "treat and resect" protocols, as well as in clinical trials for Barrett's esophagus with long-term follow-up.

Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.

Covidien, GI Solutions

University Hospitals Cleveland Medical Center

Principal Investigator

Ablation Catheter

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jeffrey Marks, MD

Subjects with radiation proctitis who met inclusion criteria

Ablation Treatment

There was no analysis of the data. Feasibility study with only one subject enrolled

Number of Participants With Adverse Events

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System	NCT01103492	Pelvic Neoplasm...	HALO90 Ablation...	18 Years -	University Hospitals Cleveland Medical Center
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System	NCT01103492	Pelvic Neoplasm...	HALO90 Ablation...	18 Years -	University Hospitals Cleveland Medical Center

Spots Global Cancer Trial Database for halo90 ablation catheter